1. Field of the Invention
The present invention relates to methods and devices for making a sterile connection, and more particularly, to methods and devices for making a sterile connection with a medicament source.
2. Description of the Related Art
Drug delivery devices in the form of infusers are known in the prior art for administering medicament to a patient. Infusers are intended for mounting onto a patient's skin for self-administration of a medicament. Activation of the infuser not only provides for injection of a needle into a patient's skin, but also to cause auto-drive of a plunger to drive medicament into the patient via the injected needle. Typical infuser constructions have the needle fixed to the reservoir. For example, U.S. Pat. No. 5,858,001 to Tsals et al., discloses an infuser that is activated through swivel displacement of a reservoir-containing body. A needle is fixed to the body to move therewith so that the swivel displacement of the body also causes the needle to penetrate the patient's skin. Other types of infusers are known, including those which use standard needle-mounted syringe barrels. With many infusers, the ability to control the insertion of the needle independent of the administration of medicament is limited.
U.S. Pat. No. 5,290,254 to Vaillancourt discloses a shielded cannula assembly that includes a tubular shield mounted over a cannula. The shield includes a resilient collapsible portion that collapses in an accordion-like manner when a longitudinal force is imposed on the shield.
U.S. Pat. No. 5,685,866 to Lopez discloses a needleless valve with a generally tubular body defining an internal cavity. The valve includes a hollow spike with a closed tip and a hole located in the tip. The spike is seated inside the cavity so that the tip is below the proximal end of the body. An annular support cuff is connected to the spike and seals off a portion of the cavity to define an upper portion of the cavity that includes the tip. The valve also includes a plastic, resilient silicone seal that fills the upper portion of cavity and the body opening, and covers the tip of the spike to present a flush surface.
U.S. Patent Publication No. 2010/00022953 discloses a conduit assembly connected to a medication receiving conduit. The conduit assembly includes a cartridge receiving conduit surrounded by a sleeve, and a conduit sterility cap. A cartridge includes a spring-loaded casing, a cartridge sterility cap, and mechanical features for connecting with the conduit assembly. Upon such connection, an end of the cartridge breaches the conduit sterility cap. Subsequently, the spring drives the casing toward the cartridge receiving conduit, impales the cartridge sterility cap on the sleeve, and connects an interior of the casing with the cartridge receiving conduit.
PCT Publication WO 2011/146166, which is hereby incorporated by reference in its entirety, discloses an infuser in which activation of an actuator causes a spring to move a stopper in a reservoir from a first position toward a second position, and also causes a needle driver to displace a patient needle from a first state toward a second state. The needle moves relative to the reservoir, and separately from the stopper.
In addition, with medical devices, such as syringes and infusion devices, making a sterile connection with a medicament storage device, such as a medicament vial, generally necessitates maintaining the sterility of all parts of the connection, or making the parts of the connection sterile immediately prior to making the connection. Improvements in the equipment and/or the process of making a sterile connection with a medicament storage device are desirable.